Background of Different Phenotypes of Coeliac Disease

• Sponsor: Tampere University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05597904
• Collaborator: Tampere University (Other), University of Helsinki (Other), University of Turku (Other), Oulu University Hospital (Other), University of Debrecen (Other), University of Trieste (Other), Oslo University Hospital (Other)
• Enrollment: 3,500
• Location: 1
• Anticipated Duration (Months): 97.7
• Patients Per Site Per Month: 35.8

Study Details

Study Description

Brief Summary

The main purpose of this study is to investigate genetic, serological, immunological and microbiata diversities between different coeliac disease phenotypes and to discover applicable prognostic markers for specific phenotypes.

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease; Dermatitis Herpetiformis	Genetic: Genetic predisposition

Detailed Description

The recognition of clinical heterogeneity has expanded the understanding of coeliac disease, but the factors contributing to this diversity remain unclear. Moreover, since coeliac disease is highly heterogeneous, there is a need for more individualized follow-up and support and implementation of more personalized follow-up guidelines.

In this study coeliac disease and dermatitis herpetiformis patients and healthy controls will be recruited. Genetic, clinical, immunological, micobiata and novel biomedical markers are compared between coeliac disease phenotypes and also controls and their prognostic value is assessed.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 3500 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Genetic and Biological Background and Follow-up of Different Phenotypes of Coeliac Disease
• Actual Study Start Date: Nov 8, 2022
• Anticipated Primary Completion Date: Dec 31, 2027
• Anticipated Study Completion Date: Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Coeliac disease patients Adult (18 years or over) patients with previous coeliac disease or dermatitis herpetiformis diagnosis	Genetic: Genetic predisposition; Assessment of genetic predisposition to various celiac disease phenotypes. No intervention.
Healthy controls 500 adult (18 years or over) friends or non-related family members of coeliac disease or dermatitis herpetiformis patients participating in the study, no previous coeliac disease or dermatitis herpetiformis diagnosis. In addition 1000 controls will be included from Biobank	Genetic: Genetic predisposition; Assessment of genetic predisposition to various celiac disease phenotypes. No intervention.

Outcome Measures

Primary Outcome Measures

1. Non-HLA variant association [baseline]

   phenotype specific non-HLA variants

Secondary Outcome Measures

1. serum transglutaminase antibodies [baseline]

   Levels of serum antibodies against transglutaminase

2. microbiata [baseline]

   skin and intestinal microbiata findings

3. quality of life measure [baseline]

   PGWB questionnaire (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)

4. gastrointestinal symptoms [baseline]

   GSRS-questionnaire (15 items with values 1-7, total score 1-7 as a mean value of all scores, higher score indicating more severe symptoms)

5. dietary adherence [baseline]

   strictness of gluten-free diet (GIP-test)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis

• Cohort 3: friend or non-related family member of coeliac disease or dermatitis herpetiformis patient

Exclusion Criteria:

• Cohorts 1-3: Age <18 years

• Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis not confirmed

• Cohort 3: coeliac disease or dermatitis herpetiformis diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University Hospital	Tampere		Finland	33521

Sponsors and Collaborators

• Tampere University Hospital
• Tampere University
• University of Helsinki
• University of Turku
• Oulu University Hospital
• University of Debrecen
• University of Trieste
• Oslo University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teea Salmi, Professor in Dermatology, Tampere University Hospital
• ClinicalTrials.gov Identifier: NCT05597904
• Other Study ID Numbers: R22088
• First Posted: Oct 28, 2022
• Last Update Posted: Jan 5, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Teea Salmi, Professor in Dermatology, Tampere University Hospital: coeliac disease; dermatitis herpetiformis; gluten-free diet; transglutaminase; microbiata
• Additional relevant MeSH terms: Celiac Disease; Dermatitis; Dermatitis Herpetiformis

Study Results

No Results Posted as of Jan 5, 2023